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View of Serum Institute of India (PTI)
View of Serum Institute of India (PTI)

Oxford vaccine: Serum rejects volunteer's claims of suffering side effects, seeks damages worth 100 cr

'Serum Institute of India is sympathetic with volunteer’s medical condition, there's absolutely no correlation with vaccine trial and his medical condition. He's falsely laying blame for his medical problems on trial,' it said

Vaccine manufacturing major Serum Institute of India on Sunday dismissed claims that a volunteer for the Covid-19 vaccine candidate being developed in its facilities had serious side effects, and had threatened to seek heavy damages for "malicious" allegations.

"Serum Institute of India is sympathetic with volunteer’s medical condition, there's absolutely no correlation with vaccine trial and his medical condition. He's falsely laying blame for his medical problems on trial," the vaccine developer said in a statement.

According to a PTI report, a 40-year-old man who took part in the 'Covishield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.

"The claim is malicious because volunteer was specifically informed by medical team that complications he suffered were independent of vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign reputation of company," the world's largest vaccine producer said in a statement.

The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial, it added.

"It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of 100 crore for the same and will defend such malicious claims," Serum Institute said.

The participant, alleged that the candidate vaccine was not safe. He also sought cancelling approval for its testing, 'manufacture and distribution', failing which legal action would be taken, according to PTI.

The Indian Council of Medical Research (ICMR), one of the sponsors besides SII, and Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man, have been served with the notice along with one to SII.

The man, the notice alleged, suffered acute encephalopathy ,damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine. The trauma he underwent after taking it 'cleary proves' that the vaccine was not safe as made out to be and all the stakeholders were trying to hide the adverse effect that the vaccine has had on him, the notice claimed.

A pyschiatric evaluation revealed mild deficit in verbal and visual memory functions and an under functioning in overall cognitive functions, it said. "He has gone through extreme sufferings, both neurologically and psychologically. The vaccine had led to a virtual neurological breakdown in him."

The notice also said the testing, manufacturing and the distribution of the vaccine should be stopped immediately failing which the man would have no other option except to take legal action against all the parties concerned. The Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating if the adverse event as claimed to have been suffered by a COVID-19 vaccine trial participant are related to the shot administered to him.

Pune-based Serum Institute of India (SII) has collaborated with Oxford University and pharmaceutical company Astra Zeneca for making the COVID-19 vaccine, 'Covidshield', and is conducting trials in India.

Meanwhile, on Saturday, Prime Minister Narendra Modi reviewed development and manufacturing process of coronavirus vaccines at facilities. Among them, he also visited the Serum Institute of India where he reviewed the progress of the 'Covishield' vaccine being made there.

With inputs from PTI

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